drugs

FLANTADIN ® Deflazacort

FLANTADIN ® a drug based on Deflazacort

THERAPEUTIC GROUP: Non-associated systemic corticosteroids

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications FLANTADIN ® Deflazacort

FLANTADIN ® is used in the treatment of dermatological, systemic, respiratory, ocular, hematologic and gastro-intestinal inflammatory diseases.

FLANTADIN ® can also be used in the treatment of allergic diseases and in case of primary or secondary adrenal cortical insufficiency, in conjunction with mineralocorticoids.

Mechanism of action FLANTADIN ® Deflazacort

The deflazacort, active ingredient of FLANTADIN ® is a synthetic corticosteroid characterized by a therapeutic efficacy decidedly superior to cortisol or prednisolone in the face of a lower incidence and severity of the side effects.

Taken orally it is rapidly absorbed at the gastrointestinal level, and metabolized in its active metabolites, which are concentrated mainly in blood and vascular cells, inhibiting the enzyme phospholipase A2.

The therapeutic efficacy of this active ingredient is due to the aforementioned activity, useful for reducing the availability of arachidonic acid and the synthesis of inflammatory mediators such as leukotrienes, prostaglandins and prostacyclins, thus preventing both vascular modifications and on-site cell recruitment inflammatory.

The inhibition upstream of the inflammatory chain supported by arachidonic acid derivatives prevents the important tissue-damaging effects of the massive activation of the inflammatory process.

After the biological activity, the metabolites are eliminated, for 24 hours after oral intake, via the kidney.

Studies carried out and clinical efficacy

1. DEFLAZACORT AND DISTROPHY OF DEUCHENNE

Long-term administration of corticosteroids in the Deuchenne pathology has proved useful in: prolonging walking for 2 to 5 years, reducing the need for surgery, improving cardiovascular function and improving the quality of life of affected patients.

2. DEFLAZACORT AND EPILEPSY

Deflazacort was as effective as the other corticosteroids in treating intractable epilepsy, but with a significant reduction in the incidence of side effects. This medicine should be considered as a possible therapeutic approach.

3. DEFLAZACORT AND HEPATITIS

Experimental study that has shown how the treatment of autoimmune hepatitis with deflazacort, can lead, in quite long periods of treatment, to a complete histological remission of the pathological picture.

Method of use and dosage

FLANTADIN ® tablets of 6 - 30 mg of Deflazacort or oral drops of 22.75 mg of deflazacort per ml of solution:

although a range of application can be indicated, between 6 and 90 mg of deflazacort per day, the formulation of the specific dosage is the exclusive competence of the doctor, who should establish this value only after a careful evaluation of the physical condition of the patient and its clinical picture.

Medical supervision throughout the therapeutic treatment is also important in the eventual need to vary the doses used, in order to keep the anti-inflammatory effect active.

Warnings FLANTADIN ® Deflazacort

To avoid the occurrence of important side effects it is advisable for the doctor to carefully evaluate all the potential risk factors, foreseeing any corrections to the normal therapeutic procedure.

Striking examples are represented by diabetic patients, for whom corticosteroid therapy should be accompanied by an adjustment of the hypoglycemic dosage, to cope with the hyperglycaemic effect of these hormones, or by patients suffering from neurological or psychiatric diseases, for which therapy with FLANTADIN ® could aggravate the clinical picture, or from patients undergoing immunizing therapy, which would vanish the protective effect following the intake of corticosteroids.

Furthermore, prolonged intake over time could result in secondary adrenal insufficiency, or peptic ulcers.

Dizziness, headache, altered perceptual abilities are just some of the neurological symptoms associated with deflazacort therapy, which could make the use of machinery and driving vehicles dangerous.

PREGNANCY AND BREASTFEEDING

The use of FLANTADIN ® in pregnancy and lactation should be avoided or in any case limited to cases of real need, under the strict supervision of a doctor.

The absence of studies at the moment does not allow us to predict the potential side effects on the health of the unborn child and of the infant.

Interactions

The concomitant intake of anticonvulsants, antibiotics, anticoagulants, bronchodilators, antacids and non-systemic anti-inflammatories, could determine the appearance of pharmacokinetically important alterations, such as to require a possible adjustment of the dosage.

Fortunately, such interactions are not described as to cause the appearance of clinically relevant effects.

Contraindications FLANTADIN ® Deflazacort

FLANTADIN ® contraindicated in case of hypersensitivity to the active ingredient or to one of its excipients, in case of active tuberculosis, peptic ulcer, simplex ocular herpes, systemic fungal infections and psychosis.

Undesirable effects - Side effects

Despite the fact that deflazacort was born with the main objective of reducing the collateral effects on the osteo-muscular apparatus, prolonged therapies and high doses can be associated with hydro-electrolytic alterations with increased risk of hypertension and heart failure, to insufficiency adrenal and endocrine alterations of various kinds, neurological and psychiatric disorders, negativization of the nitrogen balance and bone and muscle fragility.

Note

FLANTADIN ® sold only under medical prescription.

The use of FLANTADIN ® without therapeutic necessity during sports competitions constitutes doping.